Biomarker Differences in Samples From Patients With Undifferentiated Sarcomas

Completed

• Conditions: Soft Tissue Sarcoma
• Interventions: Other: laboratory biomarker analysis

• Registration Number: NCT01802125
• Lead Sponsor: Children's Oncology Group

Brief Summary

This clinical trial studies biomarker differences in samples from patients with undifferentiated sarcomas. Studying biomarker in tissue samples from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer

Detailed Description

Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Prospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Patients from ARST0332 study Sampling Method: Non-Probability Sample

PRIMARY OBJECTIVES:

I. To determine what proportion of unclassifiable sarcomas are unclassifiable because the initial evaluation was not sufficiently comprehensive versus what proportion can be regarded as "true" undifferentiated sarcoma when a comprehensive assessment has been performed.

II. To develop formal diagnostic criteria for establishing the diagnosis of undifferentiated sarcoma.

III. To determine whether undifferentiated sarcoma can be subdivided into separate and distinct pathologic entities that are distinguishable by light microscopy, immunohistochemistry, single nucleotide polymorphism (SNP) array profiling, or clinical features.

IV. To determine whether undifferentiated sarcomas with specific "actionable mutations" can be identified based on their histologic appearance, immunohistochemical staining characteristics, or SNP array profiling features.

OUTLINE:

Tissue samples are analyzed for loss of heterozygosity (LOH) and SNP array profiling using microarray and immunohistochemistry.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-27
• Study First Submitted QC: 2013-02-27
• Study First Posted: 2013-03-01
• Primary Completion: 2014-07
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-13
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• 49 cases of undifferentiated sarcomas from ARST0332 (additional cases may be ascertained as eligible for this current project that also fall under ARST0332 to be requested later if necessary)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Basic science (SNP array analysis)	laboratory biomarker analysis	Tissue samples are analyzed using laboratory biomarker analysis for LOH and SNP array profiling using microarray and immunohistochemistry.

Primary Outcome Measures

Name	Time	Method
Proportion of unclassifiable sarcomas that are unclassifiable	Baseline
Development of formal diagnostic criteria for establishing the diagnosis of undifferentiated sarcoma	Baseline
Specific "actionable mutations" that can be identified based on their histologic appearance, immunohistochemical staining characteristics, or SNP array profiling features	Baseline
Separate and distinct pathologic entities of undifferentiated sarcoma that are distinguishable by light microscopy, immunohistochemistry, SNP array profiling, or clinical features	Baseline

Trial Locations

Locations (1)

Children's Oncology Group; 🇺🇸 Monrovia, California, United States